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. 2021 Nov 12;22(1):795.
doi: 10.1186/s13063-021-05746-z.

The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial

Ana I Fernández  1 , Javier Bermejo  2 , Raquel Yotti  1 , Miguel Ángel Martínez-Gonzalez  3   4 , Alex Mira  5 , Uri Gophna  6 , Roger Karlsson  7 , Reem Al-Daccak  8 , Irene Martín-Demiguel  1 , Enrique Gutiérrez-Ibanes  1 , Dominique Charron  8 , Francisco Fernández-Avilés  1 ; MEDIMACS research team
Collaborators, Affiliations

The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial

Ana I Fernández et al. Trials. .

Abstract

Background: Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secondary prevention after an acute coronary syndrome (ACS). We hypothesized that a high-intensity Mediterranean diet intervention after an ACS decreases the vulnerability of atherosclerotic plaques by complex interactions between anti-inflammatory effects, microbiota changes and modulation of gene expression.

Methods: The MEDIMACS project is an academically funded, prospective, randomized, controlled and mechanistic clinical trial designed to address the effects of an active randomized intervention with the Mediterranean diet on atherosclerotic plaque vulnerability, coronary endothelial dysfunction and other mechanistic endpoints. One hundred patients with ACS are randomized 1:1 to a monitored high-intensity Mediterranean diet intervention or to a standard-of-care arm. Adherence to diet is assessed in both arms using food frequency questionnaires and biomarkers of compliance. The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical coherence tomography intracoronary imaging. Indices of coronary vascular physiology and changes in gastrointestinal microbiota, immunological status and protein and metabolite profiles will be evaluated as secondary endpoints.

Discussion: The results of this trial will address the key effects of dietary habits on atherosclerotic risk and will provide initial data on the complex interplay of immunological, microbiome-, proteome- and metabolome-related mechanisms by which non-pharmacological factors may impact the progression of coronary atherosclerosis after an ACS.

Trial registration: ClinicalTrials.gov NCT03842319 . Registered on 13 May 2019.

Keywords: -Omics; Atherosclerosis; Immune system; Mediterranean diet; Microbiota; Randomized controlled trial.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The MEDIMACS trial overview
Fig. 2
Fig. 2
The MEDIMACS schedule of enrolment, intervention, assessments and endpoints in accordance with the SPIRIT guideline
See this image and copyright information in PMC

References

    1. Steg PG, Mehta SR, Pollack CV, Jr, Bode C, Gaudin C, Fanouillere K, et al. Design and rationale of the treatment of acute coronary syndromes with otamixaban trial: a double-blind triple-dummy 2-stage randomized trial comparing otamixaban to unfractionated heparin and eptifibatide in non-ST-segment elevation acute coronary syndromes with a planned early invasive strategy. Am Heart J. 2012;164(6):817–24.e13. doi: 10.1016/j.ahj.2012.10.001. - DOI - PubMed
    1. Widimsky P, Holmes DR., Jr How to treat patients with ST-elevation acute myocardial infarction and multi-vessel disease? Eur Heart J. 2011;32(4):396–403. doi: 10.1093/eurheartj/ehq410. - DOI - PMC - PubMed
    1. Fox KA, Carruthers K, Steg PG, Avezum A, Granger CB, Montalescot G, et al. Has the frequency of bleeding changed over time for patients presenting with an acute coronary syndrome? The Global Registry of Acute Coronary Events. Eur Heart J. 2010;31(6):667–675. doi: 10.1093/eurheartj/ehp499. - DOI - PMC - PubMed
    1. Gutierrez E, Flammer AJ, Lerman LO, Elizaga J, Lerman A, Fernandez-Aviles F. Endothelial dysfunction over the course of coronary artery disease. Eur Heart J. 2013;34(41):3175–3181. doi: 10.1093/eurheartj/eht351. - DOI - PMC - PubMed
    1. Skjot-Arkil H, Barascuk N, Register T, Karsdal MA. Macrophage-mediated proteolytic remodeling of the extracellular matrix in atherosclerosis results in neoepitopes: a potential new class of biochemical markers. Assay Drug Dev Technol. 2010;8(5):542–552. doi: 10.1089/adt.2009.0258. - DOI - PubMed

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